510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850118Substantially Equivalent

Xma Integrated Table

Summit Industries, LLC, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850118 is the FDA 510(k) clearance record for XMA INTEGRATED TABLE, a class II device, cleared for Summit Industries, Inc. on under FDA product code IXQ (Table, Radiographic, Stationary Top). FDA records list 8 510(k) clearances for Summit Industries, Inc., from to . As of , FDA records show no recalls naming K850118.

Clearance record

Decision date
Received
(85 days to decision)
Product code
IXQ Table, Radiographic, Stationary Top
Regulation
21 CFR 892.1980
Device class
Class II
Review panel
Radiology
Applicant
Summit Industries, Inc. 2901 W Lawrence Ave., Chicago IL
Third party review
No

Clearances, product code IXQ

Trailing 12 months

FDA records hold no clearances under product code IXQ in the trailing twelve months.

FDA records show no clearances under product code IXQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260